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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EPsoriatic arthritis occurs in about 30% of patients with psoriasis and is prevalent in an estimated 0.3% to 1.0% of the general population. This article reports on results from the Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis [PALACE4; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01307423\u0026amp;atom=%2Fspmdc%2F14%2F51%2F12.atom\u0022\u003ENCT01307423\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInflammatory Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInflammatory Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EAlvin F. Wells, MD, PhD, Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA, reported results from the Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA) [PALACE4; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01307423\u0026amp;atom=%2Fspmdc%2F14%2F51%2F12.atom\u0022\u003ENCT01307423\u003C\/a\u003E]. Up to week 104, apremilast (APR) monotherapy produced clinically relevant improvements in the symptoms, physical function, and skin manifestations of PsA in patients who had not taken disease-modifying antirheumatic drugs (DMARDs).\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EPsA occurs in about 30% of patients with psoriasis and is prevalent in an estimated 0.3% to 1.0% of the general population [Gladman DD et al. \u003Cem\u003EAnn Rheum Dis.\u003C\/em\u003E 2005]. The manifestations of PsA, including enthesitis, dactylitis, swollen and tender joints, and psoriasis, are associated with impaired physical function and health-related quality of life [Carneiro S et al. \u003Cem\u003EJ Rheumatol\u003C\/em\u003E. 2013; Sakkas LI et al. \u003Cem\u003ESemin Arthritis Rheum\u003C\/em\u003E. 2013; Strand V et al. \u003Cem\u003EHealth Qual Life Outcomes\u003C\/em\u003E. 2013; Gladman DD et al. \u003Cem\u003EAnn Rheum Dis.\u003C\/em\u003E 2005].\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EAPR is an oral phosphodiesterase 4 inhibitor that regulates inflammatory mediators associated with the pathogenesis of PsA [Schafer PH et al. \u003Cem\u003EBr J Pharmacol\u003C\/em\u003E. 2010]. PALACE4 was a phase 3, double-blind, randomized, placebo-controlled, parallel-group study designed to evaluate the long-term efficacy and safety of APR treatment compared with placebo over 104 weeks. The study consisted of 3 treatment phases with a planned overall study duration of up to 5 years.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003ETo be eligible, patients were required to be DMARD-na\u00efve adults with documented PsA with a duration \u2265 3 months and with \u2265 3 swollen joints and \u2265 3 tender joints. Patients with active tuberculosis or a history of incompletely treated tuberculosis, malignancy, or joint disease other than PsA were excluded. Participants were randomized (1:1:1) to receive placebo (n = 176), APR 20 mg BID (n = 175), or APR 30 mg BID (n = 176).\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EEfficacy assessments included the American College of Rheumatology 20%\/50%\/70% improvement response criteria (ACR20\/50\/70) and the Health Assessment Questionnaire Disability Index (HAQ-DI). Safety assessments included adverse events (AEs) and clinical laboratory parameters at scheduled visits during each treatment phase (weeks 0, 4, 16, and 24 during the placebo-controlled phase; weeks 28, 40, and 52 during the blinded active treatment phase; and weeks 65, 78, 91, and 104 during the long-term open-label phase). There were no significant differences in baseline demographics and clinical characteristic among the groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EAt week 52, patients receiving APR 20 mg BID had ACR20\/50\/70 responses of 55.4%, 28.3%, and 12.0%, respectively. Patients receiving APR 30 mg BID had ACR20\/50\/70 responses of 58.0%, 29.8%, and 15.5%, respectively. The modified ACR20\/50\/70 responses were sustained through week 104.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EMean reductions from baseline in swollen tender joint count at week 104 for APR 20 mg and APR 30 mg were \u22128.7 and \u22129.5, respectively, and for tender joint count for APR 20 mg and APR 30 mg, \u221212.4 and \u221213.0, respectively. HAQ-DI scores improved for both doses of APR and at week 52 and week 104. The mean change from baseline to week 104 was \u22120.33 for APR 20 mg and \u22120.38 for APR 30 mg. The manifestations of PsA, including enthesitis, dactylitis, and psoriasis, were improved with both APR doses.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EMost AEs were mild or moderate in severity in both APR doses and exposure periods. Diarrhea and nausea were the most often reported AEs. Discontinuations due to AEs were low. Marked laboratory abnormalities were similar in both APR and exposure periods, were generally infrequent, and returned to baseline with discontinued treatment. APR continued to demonstrate an acceptable safety profile and was generally well tolerated for up to week 104.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/51\/12.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzoe5q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}